UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027768 |
|---|---|
| Receipt number | R000031811 |
| Scientific Title | Effects of heat stress and exercise training on exercise capacity, dyspnea, and health-related quality of life in patients with interstitial lung disease |
| Date of disclosure of the study information | 2017/06/15 |
| Last modified on | 2021/10/30 16:38:01 |
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Basic information
Public title
Effects of heat stress and exercise training on exercise capacity, dyspnea, and health-related quality of life in patients with interstitial lung disease
Acronym
Effects of heat stress and exercise training in interstitial lung disease
Scientific Title
Effects of heat stress and exercise training on exercise capacity, dyspnea, and health-related quality of life in patients with interstitial lung disease
Scientific Title:Acronym
Effects of heat stress and exercise training in interstitial lung disease
Region
| Japan |
Condition
Condition
interstitial lung disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to establish the impact of heat stress and exercise training on exercise capacity, dyspnea, and health-related quality of life in patients with interstitial lung disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
6-min walk distance (6 and 12 weeks)
Key secondary outcomes
isometric quadriceps force
quadriceps muscle thickness
dyspnea (mMRC dyspnea scale)
health-related QOL (SGRQ)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
heat stress
Interventions/Control_2
exercise training (pulmonary rehabilitation)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. diagnosis of ILD
2. mMRC dyspnea grade 2, 3 or 4
3. clinically stable for at least 4 weeks before recruitment
4. written, informed consent
Key exclusion criteria
1. severe orthopedic or neurological disorders
2. non-ambulatory
3. unstable cardiac disease
4. any type of pacemaker implantation
5. active skin disease or weakness of skin
6. previous participation in a pulmonary rehabilitation program
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University
Division name
Department of Cardiopulmonary Rehabilitation, Graduate School of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki 852-8520
TEL
095-819-7963
ryokozu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University
Division name
Department of Cardiopulmonary Rehabilitation, Graduate School of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki 852-8520
TEL
095-819-7963
Homepage URL
ryokozu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Graduate School of Biomedical Sciences
Address
1-7-1 Sakamoto
Tel
095-819-7963
ryokozu@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
長崎呼吸器リハビリクリニック
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 15 | Day |
Last modified on
| 2021 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031811
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
